Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 282
- 试验地点
- 25
- 主要终点
- Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
研究概览
简要总结
Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years.
Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.
详细描述
A phase II multicentre, interventional study to determine if additional staging at diagnosis with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local policy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a high risk primary colorectal malignancy
- •Have a negative CT or includes no confirmatory evidence of liver metastases
- •Is able to undergo treatment if liver metastasis is found
- •Have provided written informed consent to participate in the study
- •Be aged 16 years or over
排除标准
- •Have had a previous colorectal malignancy
- •Have metastatic disease
- •Have a synchronous second malignancy
- •Are contraindicated for MRI
- •Has a T3b or below low rectal tumour without EMVI or N1c
结局指标
主要结局
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
时间窗: 5 years after last recruit (end of trial)
Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.
次要结局
- To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.(5 years after last recruit (end of trial))
- To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.(5 years after last recruit (end of trial))
- To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.(6mth, 12mth, 18mth, 2yr, 3yr)
- To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.(5 years after last recruit (end of trial))
- To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.(5 years after last recruit (end of trial))